Caroline Freeman, Principal Consultant, IQVIA Quality Compliance
The MDR affects all medical device manufacturers that sell to the EU, and its economic impact is already being felt, not just in the cost of implementing the new requirements for new products, but ensuring that legacy products meet the MDR, as there is no grandfathering from the current EU Medical Devices Directive (MDD). Manufacturers of all medical devices above simple Class I will need the services of an MDR designated Notified Body at some time between now and May 2024, with the exact timing being dependent on the validity of existing certificates to the MDD or the Active Implantable Medical Devices Directive (AIMDD).
As we enter the late stages of the 3-year transition period for the EU Medical Devices Regulation (2017/745/EU) (MDR), it is well documented that the designation of Notified Bodies (NBs) to the Regulation is progressing slowly. Although the European Commission (EC) has stated that progress is on track (with 20 Notified Bodies expected to be designated to MDR by the end of 2019) the total number of MDR NBs is not likely to provide sufficient resource by the date of full application of the MDR in May 2020.
However, in order to function as NBs under the Medical Devices Regulations (MDR and IVDR 2017/746/EU), they have to be assessed and designated to these Regulations. Notified Bodies medical devices could not submit their applications until November 2017, since when they have been undergoing the relatively complex and slower-than-anticipated process of joint assessment. With less than eight months to go to the full application in May of next year of the MDR, there are still only five Notified Bodies designated to the MDR (and just one designated to the IVDR, as announced in the last few days).
The joint assessment process of NBs and the added burden of new requirements of the MDR on NBs mean that some NBs have reduced product scope or conformity assessment routes offered; some have voluntarily ceased medical device activity altogether; and, some may have failed the assessment. We also need to see this against a backdrop of five MDD Notified Bodies ceasing activities and another five potentially failing already under the MDD. Although there may be four new entrants to the space, it’s difficult to see how capacity will be available to match the need, and within the necessary timeframe.
If your organization is fortunate enough to be with an already-MDR-designated Notified Body, then it’s a case of establishing a timetable with them, depending on the validity of existing EC certificates. For others, having MDD certificates which are valid beyond May 2020 will allow you to take advantage of the so-called “grace period,”. But time is running out to start the process of renewing certificates under the Directive.
If your Notified Body is not yet designated, it is important to establish their progress, but also to have a back-up plan in case it fails or is late in its MDR designation. Do keep in mind, however, that switching to a different Notified Body brings difficulties as it means potentially joining the back of the queue, and this is likely to impact small- and medium-sized companies most.
Although we think that a delayed timetable for manufacturers of Class Ir (reusable surgical instruments) to achieve CE Marking under the MDR might be about to be announced, manufacturers cannot rely on a more general possible last-minute delayed application of MDR requirements.
While manufacturers have no control over the rate of designation of NBs (except perhaps to apply pressure on the relevant authorities, via trade associations), they do have control over their own level of preparedness in the key areas of technical documentation, Quality Management System (QMS), and other processes including Post-Market Surveillance (PMS) and Vigilance. We encourage manufacturers to continue in earnest to prepare to be compliant. It is critically important that manufacturers are aware of the classification of their devices in the MDR, to be ready for the conformity assessment, and that they finalize the gap analysis of technical documentation requirements, especially the Clinical Evaluation Report and clinical data.
If anything is missing, have a plan to obtain the data, whether by testing or obtaining additional clinical data, or using data from equivalent devices, if this option is still open to you. The QMS needs to be ready and auditable, with sufficient records to show that management review has been done to the new system requirements, where applicable.
It’s evident from the small flurry of documents published in recent weeks by the Medical Devices Coordination Group (MDCG) and the announcement of Notified Bodies over the last few months that the pace of work has increased at EU level, although probably not to a sufficient level to avoid the widely predicted bottleneck towards next May. Nevertheless, it’s essential that manufacturers continue their efforts to have their systems and documentation in the best possible state of preparedness depending on their particular situation.
IQVIA Quality Compliance consultants are prepared and available to support you through the process by helping to review and upgrade existing SOPs to the MDR, and by carrying out mock audits.
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